Recall Z-2745-2016— Smith & Nephew, Inc.

Name: FDA recall Z-2745-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-19

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-07-19, terminated 2018-07-10. It names one FDA 510(k) clearance: K952535. Product: Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.. Reason: Sterility compromised due to breach in sterile packaging.

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-19
Terminated: 2018-07-10
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K952535 — ACUFEX ENDOBUTTON TAPEAcufex Microsurgical, Inc.·cleared 1996-02-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: 7211015 Used during ligament reconstruction.

Reason for recall

Sterility compromised due to breach in sterile packaging

Data sourced from openFDA. This site is unofficial and independent of the FDA.